Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Late gadolinium enhancement burden on cardiac MRI
Study Overview
Brief Summary
The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.
Detailed Description
This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
DMD-CMP cohort
Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy
Intervention: Cardiac MRI (Diagnostic Test)
DMD-CMP cohort
Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy
Intervention: Blood assays (Biological)
Outcomes
Primary Outcomes
Late gadolinium enhancement burden on cardiac MRI
Time Frame: 2 years
Secondary Outcomes
- Left ventricular ejection fraction on cardiac MRI(2 years)
- Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI(2 years)
- Global T1 on cardiac MRI(2 years)
- Left ventricular systolic longitudinal strain on cardiac MRI(2 years)
- Global T2 on cardiac MRI(2 years)
- Global extracellular volume on cardiac MRI(2 years)
- NTproBNP assay in the blood(2 years)
- Troponin I assay in the blood(2 years)
- Left ventricular systolic radial strain ejection fraction on cardiac MRI(2 years)